United StatesKinos Axiom Total Ankle System with Axiom PSR, Flat‑cut (Cut Guide), REF 5831‑9006 (System Serial Numbers 18169 and 18059; Lot D‑788; UDI‑DI 00840097509945) is affected. restor3d Inc. recalled these units because they were packaged with incorrect patient‑specific cutting guides, which may cause delayed surgery, need to use standard instrumentation, reduced fixation or poor implant alignment, implant loosening/migration, or revision surgery.
What's being recalled
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Recalling firm: restor3d Inc., Durham, NC, United States.
How to identify it
System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
The hazard
Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the states of FL, CO.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)